Safety and efficacy of transvenous lead extractions for noninfectious superfluous leads in a Japanese population: A single‐center experience

Abstract

Background A challenging decision exists as whether to abandon or remove noninfectious superfluous leads during lead revisions or cardiac implantable electronic device (CIED) upgrades. There is insufficient data in the Asian population to guide decision making. Methods This study investigated the safety and efficacy of transvenous lead extractions (TLEs) in a high‐volume Japanese center. Among a total of 341 patients who underwent lead revisions or CIED upgrades between 2008 and 2018, 53 patients (16%) who underwent TLEs to remove the superfluous leads were analyzed. Results Indications for TLE were vascular issues (60%), recalled leads (21%), growth of the body size (6%), abandoned leads in young patients (6%), switch to a subcutaneous implanted cardiac defibrillator (4%), need for an MRI conditional CIED (2%), and risks of vascular injury (2%). The population included 29 patients (55%) with nonfunctional leads and 24 (45%) with functional abandoned leads. A total of 74 target leads (mean 1.4 leads/person, median lead age 6.7 years) were extracted with a complete removal achieved in 98%. All coexisting leads, intended for continued use, were not damaged. All new leads (mean 1.4 leads/person) that had been simultaneously implanted during the TLE procedures were successfully implanted. There was one minor complication (2%) involving a pericardial effusion but it did not affect the hemodynamics. Conclusions In this Japanese single center experience, the removal of noninfectious superfluous leads with TLEs seemed to be a safe and effective therapeutic option.

Study Design of the Nationwide Japanese Lead Extraction (J‐LEX) Registry: Protocol for a Prospective, Multicenter, Open Registry

“…In Japan, TLE tools and excimer laser sheaths were first approved by the MHLW, Japan in 2008. [7][8][9][10]12 The number of TLEs during the first 3 years was only 98 performed in 9 certified hospitals, and now, more than 600 transvenous lead extractions were performed in more than 50 hospitals in 2019, resulting in more than 4,000 cases over the past decade The registry items for each case in the J-LEX are not complicated but are rather simple since the basic concept of this registry is to gather all the TLE cases in Japan; however, we can collect detailed lead extraction data in all cases during the period the J-LEX will be carried out. We believe that this nationwide Japanese F I G U R E 1 Number of patients and participating institutions.…”

“…[7][8][9][10] Less invasive transvenous LEs (TLEs) may also be performed for abandoned leads in the case of a lead failure or device up-grade, and for lead-related troubles such as pain, vessel stenosis or occlusions, too many leads, tricuspid valve regurgitation, or difficulty with chest radiation therapy. [11][12][13][14] Although TLE complications seem to be acceptable, some major complications such as a cardiac tamponade and hemothorax sometimes occur and lead to a catastrophic outcome. Therefore, a careful assessment of the risk of an LE or whether or not to leave the lead should be required before the procedure.…”

“…Excimer laser sheaths were approved by the Ministry of Health and Labour Welfare (MHLW), Japan in 2008, mechanical dilator sheaths in 2015, and controlled-rotation dilator sheaths in 2018. 12 The number of TLE cases and centers has increased accordingly with all these TLE medical tools became approved in Japan. There are several preceding LE registries in North America 15,16 and European countries, 17 and the majority have collected data from selected centers to reveal the current status of LEs.…”

“…The only curative treatment of device infections is a lead extraction (LE) which has grown to be the standard procedure in Japan 7‐10 . Less invasive transvenous LEs (TLEs) may also be performed for abandoned leads in the case of a lead failure or device up‐grade, and for lead‐related troubles such as pain, vessel stenosis or occlusions, too many leads, tricuspid valve regurgitation, or difficulty with chest radiation therapy 11‐14 . Although TLE complications seem to be acceptable, some major complications such as a cardiac tamponade and hemothorax sometimes occur and lead to a catastrophic outcome.…”

Leadless pacemaker implantations after infectious pacemaker removals in octogenarians

“…All leads were extracted transvenously through a subclavian or femoral approach using the following 4 techniques; (1) manual traction using normal or locking stylets, (2) laser-assisted lead extraction using an excimer laser sheath (3) a mechanical sheath extraction using a non-powered polypropylene dilator sheath (Cook Medical, USA) or a bidirectional rotational mechanical sheath (Evolution RL, Cook Medical, USA), or (4) a snare-assisted lead extraction using various snare tools such as Goose neck snare (Medtronic, Minneapolis, MN, USA), Needle's eye snare (Cook Medical, USA), and Lassos (Osypka, GmbH, Grentzig-Whylen, Germany). 18 Following manual traction, a mechanical sheath extraction and/or laser-assisted lead extraction was selected based on whether there was a venous occlusion or stenosis, lead-lead or lead-tissue adherence, or extensive calcification. Alternatively, among those with severe adhesions in the subclavian, innominate, or superior vena cava veins, a femoral approach using the snaring technique was applied once the tip of the passive fixation lead became free.…”